AAB-MLE offers prompt, knowledgeable customer service including experienced laboratory professionals to assist you with your regulatory questions.
Contact AAB-MLE Technical Support or your State Agency if you have questions about laboratory regulations.
CLIA Regulations
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are U.S. federal standards applicable to all sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The objective of the CLIA program is to ensure quality laboratory testing. The Centers for Medicare & Medicaid Services (CMS) regulates all non-research laboratory testing performed on humans in the U.S. through the CLIA program, in partnership with the CDC and FDA. Although CLIA is a federal program, CMS State Agencies are responsible for laboratory oversight and maintaining CLIA certification records. Some states have laboratory licensing laws separate from the CLIA regulations, so please check with your State before your lab begins any patient testing.
Laboratory Related Websites
- American Association of Bioanalysts (AAB)
- American Society for Clinical Pathology (ASCP)
- Centers for Disease Control and Prevention (CDC)
- Clinical and Laboratory Standards Institute (CLSI) – standards for antimicrobial susceptibility testing and other guidelines
- Food & Drug Administration (FDA) – regulates all commercially-marketed in vitro test systems
- Occupational Safety & Health Administration (OSHA) – enforces and sets workplace safety standards, including bloodborne pathogens, electrical, chemical, and other hazards
- COLA – laboratory accreditation and education
- TJC (formerly Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
- G2’s Lab Industry Advisor the latest legal, compliance, and business developments affecting the lab industry (Note: AAB-MLE offers this publication at a discounted rate for participants. Enroll in module 142.)
Educational Resources
- AAB-MLE Continuing Education courses
- CLIA Brochures – topics include PT, calibration, lab director responsibilities, personnel competency, and QC
- CMS Clinical Labs Center – topics include Medicare billing, payment, coding, and quality
- COLA’s Laboratory Director Course – Waived Testing Toolkit, and more
- CDC’s Free Educational Materials – includes waived and PPM guides, quality, safety, and many online courses for CE credit
- TJC Complimentary Resources – covers a wide range of healthcare topics